Head of Technical Operations

Megsan Labs - A Tentamus Company is a leading US-FDA approved business, which provides analytical testing services to pharmaceutical and related companies. The services comprise elemental impurity studies, E&L studies, method development & validation and microbiological testing.

Purpose of the Role:

To help smooth functioning of testing activities in multiple food matrices, gain customer through timely deliverables and sustainable compliance.

Primary Responsibilities

Operational

• Ensure thorough evaluation and response to client queries on method feasibilities, requisites and communicate the key assumptions of scope work.
• Ensure that all project agreements, scope of work are thoroughly drafted with required details.
• Ensure that all the pre-requisites, including samples, standards, facilities, instrument, reagents and resources are made available, prior to initiation of work.
• Ensure the team reviews the contract appropriately and facilitate the availability of prerequisites on- time to execute projects.
• Approving the analyst’s qualification and ensure prior to allocation of independent work.
• Review and Approve the documents as applicable (Manuals, Standard Operating Procedures, Standard Test Procedures, Protocols, Reports etc.,).
• Guide teams in conflict resolution, clarity in scope of work in execution of projects.
• Review of project progress and resource allocation to facilitate smooth flow of projects.
• Review and monitor instruments performance and ensure that all instruments and equipment are covered under AMC and are maintained in well calibrated and functional state.
• Devise process improvement and productivity improvement plans and identify facility and capabilities up gradation.
• Identify and drive key areas of business focus.

Human Resource

• Ensure the smooth coordination between teams and team members and facilitate for the resolution harmonization across the facility.
• Identify the resource required and facilitate for the appropriate approvals.
• Selection and hiring of associates for the operation of services as needed.
• Approval of leaves on basis of work load and its management.
• Conducting the performance management and providing feedbacks timely.

Client Management

• Support teams to understand the scope of work prior to acceptance/initiation of project.
• Participate in client calls to understand the scope of work and to facilitate finalization of projects.
• Co-ordinate with BD team to understand the client needs and direct client queries to right department for further evaluation.
• Ensure the team perform thorough review of contracts appropriately prior to its acceptance.
• Participate in client communications to resolve any technical issues or unforeseen delays in project timelines.
• Ensure the project is executed and delivered by adhere to mutually agreed timelines.
• Take action to avoid delay or inform client well in advance and seek permission to extend due date.
• Review the data and interpretation of results and appropriately communicate with clients and drive the project.
• Ensure to deliver all the findings of studies and analysis are communicated to clients in appropriate form.

Quality Management

• Ensure that all the activities are performed in accordance to written procedures and necessary procedure controls are established as per regulatory requirements.
• To perform periodic review of existing procedures and processes and suggest quality improvement plans.
• Ensure the team to adhere to quality systems and supervise system periodically.
• Participate in the customer audits and certification regulatory authority audits, as needed.
• Execution and implementation of necessary CAPA as per the requirement.
• Attend the management review meeting and provide the report about the performance of the department to management during the meeting.
• Strive to ensure compliance of lab activities to all applicable regulations.

Business Objective

• Monitor daily operations of Pharma, Physical characterization, Trace, and Microbiology to align all deliverables to committed timelines.
• Measure each activity in terms of cost and/or time (if an activity can’t be measured it can’t be improved or managed).
• Devise improvement plans for all operations in-line with client expectation.
• Identify/develop suitable new capabilities to suit client requirements and business needs.
• Report internal & external customers’ opinions to the management.
• Estimate requirements on monthly / quarterly basis and indent for chemicals & consumables in sufficient advance time
• Make business plans, communicate targets to the team & business development team.
• Contribute to elevate the brand image of organization with strategic business improvement plans in co-ordination with BD team.
• Any other activity assigned by Reporting Manager/ Management.

Safety Health and Environment

• Ensure that all employees delivery duties under safe environment.
• Ensure the safety practices and procedures are adequately followed and necessary personnel protective equipment as desired by nature of job are in practice.
• Provide safety devices in consultation with management.
• Devise safe handling and disposal practices.
• Devise and develop suitable procedures to handle potent and controlled substances.
• Ensure that relevant procedure for handling of chemicals, reagents and solvents updated with current safe practices and procedures.

Secondary Responsibilities

• Get test methods validated on need basis.
• Ensure master calibration and standards’ records are maintained and verify critical calibrations.
• Develop and validate new cost effective methods in testing & training.
• Provide cross functional / divisional training.
• Motivate team, celebrate successes; listen to the analysts.
• Empower team members (objective is to create an organization which is customer responsive and proactive).
• Educate analysts on cost of rework (do it right the first time), customer time, customer emotional costs, customer out-of-pocket expenses, cost of incremental marketing (lost vs. new customers).
• Motivate analysts to upkeep time protocols, to be friendly and courteous evidenced by their smiles and cheerfulness.

Essential Qualification

Essential Experience: M Sc-Food Science. M.Sc-Food Technology,  B.Tech-Food Technology,  M.Sc-Chemistry or Analytical Chemistry with 20+ years of experience in Food testing services. Out of the total experience at least 10 years in CRO is preferred.

Requirements and skill set:

• Work experience as Head Technical/ instrumentation, preferably within Food CRO industry
• Leadership skills with the ability to set and prioritize goals
• Analytical mindset
• Communication and writing skills.
• Data driven thinking
• Excellent leadership, communication, interpersonal and customer service skills.
• Knowledge on regulatory/ certification body requirements

If you are interested in working in a fast moving, diverse and challenging role with Tentamus Group please email: keerthi.vemula@tentamus.com to submit your CV with your salary expectation!